[Federal Register Volume 88, Number 238 (Wednesday, December 13, 2023)]
[Notices]
[Pages 86338-86342]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-27308]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-0008]


Request for Nominations for Individuals and Consumer 
Organizations for Advisory Committees

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is 
requesting that any consumer organizations interested in participating 
in the selection of voting and/or nonvoting consumer representatives to 
serve on its advisory committees or panels notify FDA in writing. FDA 
is also requesting nominations for voting and/or nonvoting consumer 
representatives to serve on advisory committees and/or panels for which 
vacancies currently exist or are expected to occur in the near future. 
Nominees recommended to serve as a voting or nonvoting consumer 
representative may be self-nominated or may be nominated by a consumer 
organization. FDA seeks to include the views of individuals on its 
advisory committee regardless of their gender identification, religious 
affiliation, racial and ethnic identification, or disability status 
and, therefore, encourages nominations of appropriately qualified 
candidates from all groups.

DATES: Any consumer organization interested in participating in the 
selection of an appropriate voting or nonvoting member to represent 
consumer interests on an FDA advisory committee or panel may send a 
letter or email stating that interest to FDA (see ADDRESSES) by January 
29, 2024, for vacancies listed in this notice. Concurrently, nomination 
materials for prospective candidates should be sent to FDA (see 
ADDRESSES) by January 29, 2024. Nominations will be accepted for 
current vacancies and for those that will or may occur through December 
31, 2023.

ADDRESSES: All statements of interest from consumer organizations 
interested in participating in the selection process should be 
submitted electronically to <a href="/cdn-cgi/l/email-protection#28696b67657b7b5d4a45415b5b4147465b684e4c490640405b064f475e"><span class="__cf_email__" data-cfemail="cc8d8f83819f9fb9aea1a5bfbfa5a3a2bf8caaa8ade2a4a4bfe2aba3ba">[email protected]</span></a> or by mail to 
Advisory Committee Oversight and Management Staff, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver 
Spring, MD 20993-0002.
    Consumer representative nominations should be submitted 
electronically by logging into the FDA Advisory Committee Membership 
Nomination Portal: https://www.accessdata.fda.gov/scripts/FACTRSPortal/FACTRS/index.cfm, or by mail to Advisory Committee Oversight and 
Management Staff, 10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver 
Spring, MD 20993-0002. Additional information about becoming a member 
of an FDA advisory committee can also be obtained by visiting FDA's 
website at https://www.fda.gov/AdvisoryCommittees/default.htm.

FOR FURTHER INFORMATION CONTACT: For questions relating to 
participation in the selection process: Kimberly Hamilton, Advisory 
Committee Oversight and Management Staff, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 32, Rm. 5122, Silver Spring, MD 20993-
0002, 301-796-8220, <a href="/cdn-cgi/l/email-protection#044f6d69666176687d2a4c65696d68706b6a446260652a6c6c772a636b72"><span class="__cf_email__" data-cfemail="5f1436323d3a2d332671173e3236332b30311f393b3e7137372c71383029">[email protected]</span></a>.
    For questions relating to specific advisory committees or panels, 
contact the appropriate contact person listed in table 1.

                  Table 1--Advisory Committee Contacts
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             Contact person                       Committee/panel
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Rakesh Raghuwanshi, Office of the Chief   FDA Science Board Advisory
 Scientist, Food and Drug                  Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 1, Rm. 3309, Silver Spring,
 MD 20993-0002, 301-796-4769,
 <a href="/cdn-cgi/l/email-protection#3c6e5d57594f54126e5d5b54494b5d524f54557c5a585d1254544f125b534a"><span class="__cf_email__" data-cfemail="6735060c02140f493506000f12100609140f0e27010306490f0f1449000811">[email protected]</span></a>.
Prabhakara Atreya, Center for Biologics   Allergenic Products Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 71, Rm. 1226, Silver
 Spring, MD 20993-0002, 240-402-8006,
 <a href="/cdn-cgi/l/email-protection#d080a2b1b2b8b1bbb1a2b1fe91bca4a2b5a9b190b6b4b1feb8b8a3feb7bfa6"><span class="__cf_email__" data-cfemail="613113000309000a0013004f200d1513041800210705004f0909124f060e17">[email protected]</span></a>.
Moon Hee Choi, Center for Drug            Anesthetic and Analgesic Drug
 Evaluation and Research, Food and Drug    Products Advisory Committee,
 Administration, 10903 New Hampshire       Non-Prescription Drugs
 Ave., Bldg. 31, Rm. 2434, Silver          Advisory Committee.
 Spring, MD 20993-0002, 301-796-2894,
 <a href="/cdn-cgi/l/email-protection#9dd0f2f2f3d5f8f8b3def5f2f4ddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="91dcfefeffd9f4f4bfd2f9fef8d1f7f5f0bff9f9e2bff6fee7">[email protected]</span></a>.
She-Chia Jankowski, Center for Drug       Antimicrobial Drugs Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 51, Rm. 6178, Silver
 Spring, MD 20993-0002, 240-402-5343,
 <a href="/cdn-cgi/l/email-protection#16457e733b557e7f77385c77787d7961657d7f56707277387e7e6538717960"><span class="__cf_email__" data-cfemail="eebd868bc3ad86878fc0a48f808581999d8587ae888a8fc086869dc0898198">[email protected]</span></a>.
Jessica Seo, Center for Drug Evaluation   Peripheral and Central Nervous
 and Research, Food and Drug               System Drugs Advisory
 Administration, 10903 New Hampshire       Committee.
 Ave., Bldg. 31, Rm. 2412, Silver
 Spring, MD 20993-0002, 301-796-7699,
 <a href="/cdn-cgi/l/email-protection#054f6076766c66642b56606a456361642b6d6d762b626a73"><span class="__cf_email__" data-cfemail="377d5244445e54561964525877515356195f5f4419505841">[email protected]</span></a>.
Yvette Waples, Center for Drug            Cardiovascular and Renal Drugs
 Evaluation and Research, Food and Drug    Advisory Committee, Medical
 Administration, 10903 New Hampshire       Imaging Drugs Advisory
 Ave., Bldg. 31, Rm. 2510, Silver          Committee.
 Spring, MD 20993-0002, 301-796-9034,
 <a href="/cdn-cgi/l/email-protection#59002f3c2d2d3c770e3829353c2a193f3d387731312a773e362f"><span class="__cf_email__" data-cfemail="c49db2a1b0b0a1ea93a5b4a8a1b784a2a0a5eaacacb7eaa3abb2">[email protected]</span></a>.

[[Page 86339]]

 
LaToya Bonner, Center for Drug            Endocrinologic and Metabolic
 Evaluation and Research, Food and Drug    Drugs Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2428, Silver
 Spring, MD 20993-0002, 301-796-2855,
 <a href="/cdn-cgi/l/email-protection#81cde0d5eef8e0afc3eeefefe4f3c1e7e5e0afe9e9f2afe6eef7"><span class="__cf_email__" data-cfemail="eea28fba81978fc0ac8180808b9cae888a8fc086869dc0898198">[email protected]</span></a>.
Takyiah Stevenson, Center for Drug        Pharmacy Compounding Advisory
 Evaluation and Research, Food and Drug    Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2406, Silver
 Spring, MD 20993-0002, 240-402-2507,
 <a href="/cdn-cgi/l/email-protection#0f5b6e6476666e67215c7b6a796a617c60614f696b6e2167677c21686079"><span class="__cf_email__" data-cfemail="6135000a180800094f32150417040f120e0f210705004f0909124f060e17">[email protected]</span></a>.
Joyce Frimpong, Center for Drug           Psychopharmacologic Drugs
 Evaluation and Research, Food and Drug    Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 31, Rm. 2438, Silver
 Spring, MD 20993-0002, 301-796-7973,
 <a href="/cdn-cgi/l/email-protection#1e5471677d7b30586c77736e7170795e787a7f3076766d30797168"><span class="__cf_email__" data-cfemail="12587d6b71773c54607b7f627d7c75527476733c7a7a613c757d64">[email protected]</span></a>.
Candace Nalls, Center for Devices and     Anesthesiology and Respiratory
 Radiological Health, Food and Drug        Therapy Devices Panel;
 Administration, 10903 New Hampshire       Clinical Chemistry and
 Ave., Bldg. 66, Rm. 5211, Silver          Clinical Toxicology Devices
 Spring, MD 20993-0002, 301-636-0510,      Panel; Ear, Nose and Throat
 <a href="/cdn-cgi/l/email-protection#9fdcfef1fbfefcfab1d1fef3f3ecdff9fbfeb1f7f7ecb1f8f0e9"><span class="__cf_email__" data-cfemail="286b49464c494b4d06664944445b684e4c490640405b064f475e">[email protected]</span></a>.                Devices Panel;
                                           Gastroenterology-Urology
                                           Devices Panel; General and
                                           Plastic Surgery Devices
                                           Panel.
James Swink, Center for Devices and       Circulatory System Devices
 Radiological Health, Food and Drug        Panel; Microbiology Devices
 Administration, 10903 New Hampshire       Panel.
 Ave., Bldg. 66, Rm. 5211, Silver
 Spring, MD 20993-0002, 301-796-6313,
 <a href="/cdn-cgi/l/email-protection#682209050d1b463b1f010603280e0c094600001b460f071e"><span class="__cf_email__" data-cfemail="d59fb4b8b0a6fb86a2bcbbbe95b3b1b4fbbdbda6fbb2baa3">[email protected]</span></a>.
Akinola Awojope, Center for Devices and   Dental Products Panel;
 Radiological Health, Food and Drug        Orthopaedic and
 Administration, 10903 New Hampshire       Rehabilitation Devices Panel.
 Ave., Bldg. 66, Rm. 5216, Silver
 Spring, MD 20993-0002, 301-636-0512,
 <a href="/cdn-cgi/l/email-protection#e1a08a888f8e8d80cfa0968e8b8e9184a1878580cf898992cf868e97"><span class="__cf_email__" data-cfemail="89c8e2e0e7e6e5e8a7c8fee6e3e6f9ecc9efede8a7e1e1faa7eee6ff">[email protected]</span></a>.
Jarrod Collier, Center for Devices and    General Hospital and Personal
 Radiological Health, Food and Drug        Use Devices Panel; Hematology
 Administration, 10903 New Hampshire       and Pathology Devices Panel;
 Ave., Bldg. 71, Rm. 1333, Silver          Molecular and Clinical
 Spring, MD 20993-0002, 240-672-5763,      Genetics Panel; Ophthalmic
 <a href="/cdn-cgi/l/email-protection#5f153e2d2d303b711c303333363a2d1f393b3e7137372c71383029"><span class="__cf_email__" data-cfemail="d19bb0a3a3beb5ff92bebdbdb8b4a391b7b5b0ffb9b9a2ffb6bea7">[email protected]</span></a>.               Devices Panel; Radiological
                                           Devices Panel.
James Swink, Center for Devices and       National Mammography Quality
 Radiological Health, Food and Drug        Assurance Advisory Committee.
 Administration, 10903 New Hampshire
 Ave., Bldg. 66, Rm. 5211, Silver
 Spring, MD 20993-0002, 301-796-6313,
 <a href="/cdn-cgi/l/email-protection#eea48f838b9dc0bd99878085ae888a8fc086869dc0898198"><span class="__cf_email__" data-cfemail="f0ba919d9583dea387999e9bb0969491de989883de979f86">[email protected]</span></a>.
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SUPPLEMENTARY INFORMATION: FDA is requesting nominations for voting 
and/or nonvoting consumer representatives for the vacancies listed in 
table 2:

      Table 2--Committee Descriptions, Type of Consumer Representative Vacancy, and Approximate Date Needed
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   Committee/panel/areas of expertise
                 needed                             Type of vacancy                 Approximate date needed
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FDA Science Board Advisory Committee--    1--Voting.........................  Immediately.
 The Science Board provides advice to
 the Commissioner of Food and Drugs
 Administration (Commissioner) and other
 appropriate officials on specific
 complex scientific and technical issues
 important to FDA and its mission,
 including emerging issues within the
 scientific community. Additionally, the
 Science Board provides advice that
 supports the Agency in keeping pace
 with technical and scientific
 developments, including in regulatory
 science; and input into the Agency's
 research agenda, and on upgrading its
 scientific and research facilities and
 training opportunities. It also
 provides, where requested, expert
 review of Agency-sponsored intramural
 and extramural scientific research
 programs.
Allergenic Products Advisory Committee--  1--Voting.........................  Immediately.
 Knowledgeable in the fields of allergy,
 immunology, pediatrics, internal
 medicine, biochemistry, and related
 specialties.
Anesthetic and Analgesic Drug Products    1--Voting.........................  Immediately.
 Advisory Committee--Knowledgeable in
 the fields of anesthesiology,
 analgesics (such as: abuse-deterrent
 opioids, novel analgesics, and issues
 related to opioid abuse) epidemiology
 or statistics, and related specialties.
Non-Prescription Drugs Advisory           1--Voting.........................  Immediately.
 Committee--Knowledgeable in the fields
 of internal medicine, family practice,
 clinical toxicology, clinical
 pharmacology, pharmacy, dentistry, and
 related specialties.
Antimicrobial Drugs Advisory Committee--  1--Voting.........................  Immediately.
 Knowledgeable in the fields of
 infectious disease, internal medicine,
 microbiology, pediatrics, epidemiology
 or statistics, and related specialties.
Peripheral and Central Nervous Systems    1--Voting.........................  Immediately.
 Drugs Advisory Committee--Knowledgeable
 in the fields of neurology,
 neuropharmacology, neuropathology,
 otolaryngology, epidemiology or
 statistics, and related specialties.
Cardiovascular and Renal Drugs Advisory   1--Voting.........................  Immediately.
 Committee--Knowledgeable in the fields
 of cardiology, hypertension,
 arrhythmia, angina, congestive heart
 failure, diuresis, and biostatistics.
Medical Imaging Drugs Advisory            1--Voting.........................  Immediately.
 Committee--Knowledgeable in the fields
 of nuclear medicine, radiology,
 epidemiology, statistics, and related
 specialties.
Endocrinologic and Metabolic Drugs        1--Voting.........................  Immediately.
 Advisory Committee--Knowledgeable in
 the fields of endocrinology,
 metabolism, epidemiology or statistics,
 and related specialties.
Pharmacy Compounding Advisory Committee-- 1--Voting.........................  Immediately.
 Knowledgeable in the fields of
 pharmaceutical compounding,
 pharmaceutical manufacturing, pharmacy,
 medicine, and related specialties.
Psychopharmacologic Drugs Advisory        1--Voting.........................  Immediately.
 Committee--Knowledgeable in the fields
 of psychopharmacology, psychiatry,
 epidemiology or statistics, and related
 specialties.

[[Page 86340]]

 
Anesthesiology and Respiratory Therapy    1--Nonvoting......................  Immediately.
 Devices Panel--Anesthesiologists,
 pulmonary medicine specialists, or
 other experts who have specialized
 interests in ventilator support,
 pharmacology, physiology, or the
 effects and complications of anesthesia.
Clinical Chemistry and Clinical           1--Nonvoting......................  Immediately.
 Toxicology Devices Panel--Doctor of
 Medicine or Philosophy with experience
 in clinical chemistry (e.g., cardiac
 markers), clinical toxicology, clinical
 pathology, clinical laboratory
 medicine, and endocrinology.
Ear, Nose and Throat Devices Panel--      1--Nonvoting......................  Immediately.
 Otologists, neurotologists, and
 audiologists.
Gastroenterology-Urology Devices Panel--  1--Nonvoting......................  Immediately.
 Gastroenterologists, urologists, and
 nephrologists.
General and Plastic Surgery Devices       1--Nonvoting......................  Immediately.
 Panel--Surgeons (general, plastic,
 reconstructive, pediatric, thoracic,
 abdominal, pelvic and endoscopic);
 dermatologists; experts in
 biomaterials, lasers, wound healing,
 and quality of life; and
 biostatisticians.
Circulatory System Devices Panel--        1--Nonvoting......................  Immediately.
 Interventional cardiologists,
 electrophysiologists, invasive
 (vascular) radiologists, vascular and
 cardiothoracic surgeons, and
 cardiologists with special interest in
 congestive heart failure.
Microbiology Devices Panel--Clinicians    1--Nonvoting......................  Immediately.
 with an expertise in infectious
 disease, e.g., pulmonary disease
 specialists, sexually transmitted
 disease specialists, pediatric
 infectious disease specialists, experts
 in tropical medicine and emerging
 infectious diseases, mycologists;
 clinical microbiologists and
 virologists; clinical virology and
 microbiology laboratory directors, with
 expertise in clinical diagnosis and in
 vitro diagnostic assays, e.g.,
 hepatologists; molecular biologists.
Dental Products Panel--Dentists,          1--Nonvoting......................  Immediately.
 engineers and scientists who have
 expertise in the areas of dental
 implants, dental materials,
 periodontology, tissue engineering, and
 dental anatomy.
Obstetrics and Gynecology Devices Panel-- 1--Nonvoting......................  Immediately.
 Experts in perinatology, embryology,
 reproductive endocrinology, pediatric
 gynecology, gynecological oncology,
 operative hysteroscopy, pelviscopy,
 electrosurgery, laser surgery, assisted
 reproductive technologies,
 contraception, postoperative adhesions,
 and cervical cancer and colposcopy;
 biostatisticians and engineers with
 experience in obstetrics/gynecology
 devices; urogynecologists; experts in
 breast care; experts in gynecology in
 the older patient; experts in
 diagnostic (optical) spectroscopy;
 experts in midwifery; labor and
 delivery nursing.
Orthopaedic and Rehabilitation Devices    1--Nonvoting......................  Immediately.
 Panel--Orthopedic surgeons (joint
 spine, trauma, and pediatric);
 rheumatologists; engineers (biomedical,
 biomaterials, and biomechanical);
 experts in rehabilitation medicine,
 sports medicine, and connective tissue
 engineering; and biostatisticians.
General Hospital and Personal Use         1--Nonvoting......................  Immediately.
 Devices Panel--Internists,
 pediatricians, neonatologists,
 endocrinologists, gerontologists,
 nurses, biomedical engineers, or
 microbiologists/infection control
 practitioners or experts.
Hematology and Pathology Devices Panel--  1--Nonvoting......................  Immediately.
 Hematologists (benign and/or malignant
 hematology), hematopathologists
 (general and special hematology,
 coagulation and hemostasis, and
 hematological oncology), gynecologists
 with special interests in gynecological
 oncology, cytopathologists, and
 molecular pathologists with special
 interests in development of predictive
 biomarkers.
Molecular and Clinical Genetics Devices   1--Nonvoting......................  Immediately.
 Panel--Experts in human genetics and in
 the clinical management of patients
 with genetic disorders, e.g.,
 pediatricians, obstetricians,
 neonatologists. The Agency is also
 interested in considering candidates
 with training in inborn errors of
 metabolism, biochemical and/or
 molecular genetics, population
 genetics, epidemiology, and related
 statistical training. Additionally,
 individuals with experience in genetic
 counseling, medical ethics, and
 ancillary fields of study will be
 considered.
Ophthalmic Devices Panel--                1--Nonvoting......................  Immediately.
 Ophthalmologists with expertise in
 corneal-external disease, vitreo-
 retinal surgery, glaucoma, ocular
 immunology, ocular pathology;
 optometrists; vision scientists; and
 ophthalmic professionals with expertise
 in clinical trial design, quality-of-
 life assessment, electrophysiology, low-
 vision rehabilitation, and
 biostatistics.
Radiological Devices Panel--Physicians    1--Nonvoting......................  Immediately.
 with experience in general radiology,
 mammography, ultrasound, magnetic
 resonance, computed tomography, other
 radiological subspecialties, and
 radiation oncology; scientists with
 experience in diagnostic devices,
 radiation physics, statistical
 analysis, digital imaging, and image
 analysis.
National Mammography Quality Assurance    3--Voting.........................  Immediately.
 Advisory Committee--Physician,
 practitioner, or other health
 professional whose clinical practice,
 research specialization, or
 professional expertise includes a
 significant focus on mammography.
----------------------------------------------------------------------------------------------------------------

I. Functions and General Description of the Committee Duties

A. FDA Science Board Advisory Committee

    The Science Board Advisory Committee (Science Board) provides 
advice to the Commissioner of Food and Drugs (Commissioner) and other 
appropriate officials on specific complex scientific and technical 
issues important to FDA and its mission, including emerging issues 
within the scientific community. Additionally, the Science Board 
provides advice that supports the Agency in keeping pace with technical 
and scientific developments, including in regulatory science, and input 
into the Agency's research agenda and on upgrading its scientific and 
research facilities and training opportunities. It also provides, where 
requested, expert review of Agency-sponsored intramural and extramural 
scientific research programs.

[[Page 86341]]

B. Allergenic Products Advisory Committee

    Reviews and evaluates available data concerning the safety, 
effectiveness, and adequacy of labeling of marketed and investigational 
allergenic biological products or materials that are administered to 
humans for the diagnosis, prevention, or treatment of allergies and 
allergic disease and makes appropriate recommendations to the 
Commissioner regarding the affirmation or revocation of biological 
product licenses; on the safety, effectiveness, and labeling of the 
products; on clinical and laboratory studies of such products; on 
amendments or revisions to regulations governing the manufacture, 
testing, and licensing of allergenic biological products; and on the 
quality and relevance of FDA's research programs.

C. Anesthetic and Analgesic Drug Products Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products, 
including analgesics (e.g., abuse-deterrent opioids, novel analgesics, 
and issues related to opioid abuse) and drug products for use in 
anesthesiology, and makes appropriate recommendations to the 
Commissioner.

D. Nonprescription Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of over-the-counter (nonprescription) human drug 
products, or any other FDA-regulated product, for use in the treatment 
of a broad spectrum of human symptoms and diseases, and advises the 
Commissioner either on the promulgation of monographs establishing 
conditions under which these drugs are generally recognized as safe and 
effective and not misbranded or on the approval of new drug 
applications for such drugs. The Committee serves as a forum for the 
exchange of views regarding the prescription and nonprescription 
status, including switches from one status to another, of these various 
drug products and combinations thereof. The Committee may also conduct 
peer review of Agency-sponsored intramural and extramural scientific 
biomedical programs in support of FDA's mission and regulatory 
responsibilities.

E. Antimicrobial Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of infectious diseases and disorders.

F. Arthritis Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of arthritis, rheumatism, and related diseases.

G. Peripheral and Central Nervous System Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of neurologic diseases.

H. Cardiovascular and Renal Drugs Advisory Committee

    Reviews and evaluates available data concerning the safety and 
effectiveness of marketed and investigational human drug products for 
use in the treatment of cardiovascular and renal disorders.

I. Medical Imaging Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in 
diagnostic and therapeutic procedures using radioactive pharmaceuticals 
and contrast media used in diagnostic radiology.

J. Endocrinologic and Metabolic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
treatment of endocrine and metabolic disorders.

K. Pharmacy Compounding Advisory Committee

    Provides advice on scientific, technical, and medical issues 
concerning drug compounding under sections 503A and 503B of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act), and, as required, any other 
product for which FDA has regulatory responsibility.

L. Psychopharmacologic Drugs Advisory Committee

    Reviews and evaluates data concerning the safety and effectiveness 
of marketed and investigational human drug products for use in the 
practice of psychiatry and related fields.

M. Medical Devices Advisory Committee Panels

    The Medical Devices Advisory Committee has established certain 
panels to review and evaluate data on the safety and effectiveness of 
marketed and investigational devices and make recommendations for their 
regulation. With the exception of the Medical Devices Dispute 
Resolution Panel, each panel, according to its specialty area: (1) 
advises on the classification or reclassification of devices into one 
of three regulatory categories and advises on any possible risks to 
health associated with the use of devices; (2) advises on formulation 
of product development protocols; (3) reviews premarket approval 
applications for medical devices; (4) reviews guidelines and guidance 
documents; (5) recommends exemption of certain devices from the 
application of portions of the FD&C Act; (6) advises on the necessity 
to ban a device; and (7) responds to requests from the Agency to review 
and make recommendations on specific issues or problems concerning the 
safety and effectiveness of devices. With the exception of the Medical 
Devices Dispute Resolution Panel, each panel, according to its 
specialty area, may also make appropriate recommendations to the 
Commissioner on issues relating to the design of clinical studies 
regarding the safety and effectiveness of marketed and investigational 
devices.
    The Medical Devices Dispute Resolution Panel provides advice to the 
Commissioner on complex or contested scientific issues between FDA and 
medical device sponsors, applicants, or manufacturers relating to 
specific products, marketing applications, regulatory decisions and 
actions by FDA, and Agency guidance and policies. The Panel makes 
recommendations on issues that are lacking resolution, are highly 
complex in nature, or result from challenges to regular advisory panel 
proceedings or Agency decisions or actions.

N. National Mammography Quality Assurance Advisory Committee

    Advises the Agency on the development of appropriate quality 
standards and regulations for mammography facilities; standards and 
regulations for bodies accrediting mammography facilities under this 
program; regulations with respect to sanctions; procedures for 
monitoring compliance with standards; establishing a mechanism to 
investigate consumer complaints; and reporting new developments 
concerning breast imaging that should be considered in the oversight of 
mammography facilities. The Committee also advises on determining 
whether there exists a shortage of mammography facilities in

[[Page 86342]]

rural and health professional shortage areas and determining the 
effects of personnel on access to the services of such facilities in 
such areas; determining whether there will be a sufficient number of 
medical physicists after October 1, 1999; and determining the costs and 
benefits of compliance with these requirements.

II. Criteria for Members

    Persons nominated for membership as consumer representatives on 
committees or panels should meet the following criteria: (1) 
demonstrate an affiliation with and/or active participation in consumer 
or community-based organizations, (2) be able to analyze technical 
data, (3) understand research design, (4) discuss benefits and risks, 
and (5) evaluate the safety and efficacy of products under review. The 
consumer representative should be able to represent the consumer 
perspective on issues and actions before the advisory committee; serve 
as a liaison between the committee and interested consumers, 
associations, coalitions, and consumer organizations; and facilitate 
dialogue with the advisory committees on scientific issues that affect 
consumers.

III. Selection Procedures

    Selection of members representing consumer interests is conducted 
through procedures that include the use of organizations representing 
the public interest and public advocacy groups. These organizations 
recommend nominees for the Agency's selection. Representatives from the 
consumer health branches of Federal, State, and local governments also 
may participate in the selection process. Any consumer organization 
interested in participating in the selection of an appropriate voting 
or nonvoting member to represent consumer interests should send a 
letter stating that interest to FDA (see ADDRESSES) within 30 days of 
publication of this document.
    Within the subsequent 45 days, FDA will compile a list of consumer 
organizations that will participate in the selection process and will 
forward to each such organization a ballot listing at least two 
qualified nominees selected by the Agency based on the nominations 
received, together with each nominee's current curriculum vitae or 
r[eacute]sum[eacute]. Ballots are to be filled out and returned to FDA 
within 30 days. The nominee receiving the highest number of votes 
ordinarily will be selected to serve as the member representing 
consumer interests for that particular advisory committee or panel.

IV. Nomination Procedures

    Any interested person or organization may nominate one or more 
qualified persons to represent consumer interests on the Agency's 
advisory committees or panels. Self-nominations are also accepted. 
Nominations must include a current, complete r[eacute]sum[eacute] or 
curriculum vitae for each nominee and a signed copy of the 
Acknowledgement and Consent form available at the FDA Advisory 
Nomination Portal (see ADDRESSES), and a list of consumer or community-
based organizations for which the candidate can demonstrate active 
participation.
    Nominations must also specify the advisory committee(s) or panel(s) 
for which the nominee is recommended. In addition, nominations must 
also acknowledge that the nominee is aware of the nomination unless 
self-nominated. FDA will ask potential candidates to provide detailed 
information concerning such matters as financial holdings, employment, 
and research grants and/or contracts to permit evaluation of possible 
sources of conflicts of interest. Members will be invited to serve for 
terms of up to 4 years.
    FDA will review all nominations received within the specified 
timeframes and prepare a ballot containing the names of qualified 
nominees. Names not selected will remain on a list of eligible nominees 
and be reviewed periodically by FDA to determine continued interest. 
After selecting qualified nominees for the ballot, FDA will provide 
those consumer organizations that are participating in the selection 
process with the opportunity to vote on the listed nominees. Only 
organizations vote in the selection process. Persons who nominate 
themselves to serve as voting or nonvoting consumer representatives 
will not participate in the selection process.
    This notice is issued under the Federal Advisory Committee Act (5 
U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

    Dated: December 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-27308 Filed 12-12-23; 8:45 am]
BILLING CODE 4164-01-P


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